The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles.

PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

The combined system utilizes the MR for radiation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

Device Description

The GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. The system is designed for whole body oncology, neurology and cardiology examinations. The SIGNA PET/MR system provides simultaneous acquisition of high resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a detachable patient table and both the acquisition and processing workstations with associated software.

The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil and a transmit/receive whole body radiofrequency coil. The system includes patient adaptable RF shimming capabilities. The SIGNA PET detectors are integrated into the MR bore. This allows for simultaneous, precisely aligned whole body MR and PET acquisitions. The PET subsystem supports Time of Flight (ToF) coincidence detection. The SIGNA PET/MR software is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The modifications to this system include the MotionFree Brain software feature, which allows users the flexibility to correct patient head motion using the acquired PET data from the exam, without the need of external tracking devices, additional MR data, or other motion tracking data schemes.

AI/ML Overview

The provided text describes the 510(k) summary for the GE SIGNA PET/MR system with a specific modification: the "MotionFree Brain" software feature. This feature aims to correct patient head motion in PET data without external tracking devices or additional MR data.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. However, it states that "Performance testing on phantoms as part of non-clinical testing demonstrated MotionFree Brain achieved performance claims for Quantitation, Temporal Resolution, and Spatial Accuracy." For clinical testing, the acceptance was based on reader preference and confirmation that the feature could be "used safely and effectively in a clinical setting."

Implicit Acceptance Criteria and Reported Performance (derived from text):

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Quantitation (Phantom)	Performance claims achieved.	Achieved performance claims for Quantitation.
Temporal Resolution (Phantom)	Performance claims achieved.	Achieved performance claims for Temporal Resolution.
Spatial Accuracy (Phantom)	Performance claims achieved.	Achieved performance claims for Spatial Accuracy.
Clinical Efficacy/Safety	Device can be used safely and effectively in a clinical setting; no new questions of safety and effectiveness were raised; performs as well as or better than the predicate device.	"Clinical testing confirms that MotionFree Brain can be used safely and effectively in a clinical setting." "No new questions of safety and effectiveness were raised during nonclinical testing." "Testing demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device." Readers were asked to report their preference, implying that a favorable preference was the goal.
Substantial Equivalence	Software feature is as safe and effective as the predicate, and does not raise different questions of safety and effectiveness.	"The SIGNA PET/MR with the modified software feature has the same intended use as the predicate... performance data demonstrating that the feature is as safe and effective as the predicate, and does not raise different questions of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not explicitly state the numerical sample size (number of cases or patients) used for the clinical test set. It mentions "randomly labeled cases."
Data Provenance: The document does not specify the country of origin for the data. The study was described as a "retrospective blind study."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: The document refers to "board-certified readers" (plural), indicating more than one expert. The exact number is not provided.
Qualifications of Experts: The experts were "board-certified readers." No further details on years of experience or specific specializations (e.g., neuroradiologist) are given.

4. Adjudication Method for the Test Set

The document states: "The readers were blinded to feature use (e.g. whether feature was enabled or disabled), report case history, as well as to the assessments made by the other readers. The readers were asked to complete an assessment, including additional commentary, and report their preference on the pair of image series presented."

This describes a blinded read comparison where readers evaluated paired images (with and without the feature). The adjudication method primarily involved readers reporting their preference rather than a formal consensus or 2+1/3+1 type of adjudication. The text implies individual reader assessment and preference reporting, not a group adjudication to establish a "ground truth" through consensus for each case regarding motion correction per se.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

MRMC Study: An "external reader evaluation study was performed for MotionFree Brain. The retrospective blind study involved board-certified readers who were asked to evaluate randomly labeled cases that were reconstructed with and without MotionFree Brain." This structure implies an MRMC design, where multiple readers evaluate multiple cases under different conditions (with/without AI assistance).
Effect Size of Human Readers Improvement: The document does not quantify the effect size (e.g., AUC, sensitivity, specificity improvement) of how much human readers improved with AI (MotionFree Brain) assistance vs. without. It focuses on reader preference and overall safety/effectiveness conclusion.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document describes "Performance testing on phantoms" for "Quantitation, Temporal Resolution, and Spatial Accuracy." This can be considered a form of standalone performance evaluation for the algorithm's core functionality, as it assesses the algorithm's output (reconstructed image quality metrics) on controlled phantom data, independent of human interpretation for diagnostic tasks.

7. Type of Ground Truth Used

For Phantom Testing: The ground truth was based on the known, controlled characteristics of the phantoms used, against which the "Quantitation, Temporal Resolution, and Spatial Accuracy" were measured.
For Clinical/Reader Study: The "ground truth" was indirectly established through the comparative assessment and preference of experienced, board-certified readers. It's not a definitive clinical outcome (e.g., pathology, long-term follow-up) but rather a relative assessment of image quality and diagnostic confidence as perceived by experts when comparing images with and without motion correction. The study design focused on assessing the impact of the feature on the interpretability by clinicians, rather than establishing a true disease status for each patient.

8. Sample Size for the Training Set

The document does not provide any information about the training set size for the MotionFree Brain software feature. This information is typically proprietary and not included in a 510(k) summary unless specifically requested or deemed critical for demonstrating substantial equivalence. Given that the feature "derives head motion information from the PET data" and "measures and incorporates the rigid-body motion information into the PET reconstruction," it likely involves algorithmic processing rather than a purely deep learning approach requiring a massive labeled training set in the conventional sense, though validation or tuning would still involve data.

9. How the Ground Truth for the Training Set Was Established

Since no information on the training set (or its existence as a distinct "training set" in a machine learning sense) is provided, there is no description of how its ground truth was established. If the algorithm is rule-based or model-based rather than solely data-driven (e.g., deep learning), a "training set" with ground truth in the supervised learning sense might not be applicable. The description ("MotionFree Brain derives head motion information from the PET data... measures and incorporates the rigid-body motion information into the PET reconstruction, correcting the position of each coincidence event") suggests a more deterministic or model-based approach to motion correction.

Summary

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January 20, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

GE Medical Systems, LLC % Mr. Brian Zielski Regulatory Affairs Leader 3200 N. Grandview Blvd. WAUKESHA WI 53188

Re: K213709

Trade/Device Name: SIGNA PET/MR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: OUO Dated: November 22, 2021 Received: November 24, 2021

Dear Mr. Zielski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Julie Sullivan Associate Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K213709

Device Name SIGNA PET/MR

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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510(k) Summary

K213709

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	November 22, 2021
Submitter:	GE Medical Systems, LLC3200 N. Grandview Blvd.Waukesha, WI 53188
Primary Contact:	Brian R. ZielskiRegulatory Affairs LeaderPhone: 262-227-3596Email: brian.zielski@ge.com
Secondary Contact:	Andrew MendenSenior Regulatory Affairs ManagerPhone: 262-308-5719Email: andrew.menden@ge.com
Device Trade Name:	SIGNA PET/MR
Common / Usual Name:	Magnetic Resonance Diagnostic Device / PositronEmission Tomography (PET) System
Classification Name:	Emission Computed Tomography System 21 CFR892.1200
Product Code:	OUO
Predicate Device(s):	SIGNA PET/MR (K163619)
Device Description:	The GE SIGNA PET/MR system is a combined MagneticResonance Diagnostic Device (MRDD) and PositronEmission Tomography (PET) scanner. The system isdesigned for whole body oncology, neurology andcardiology examinations. The SIGNA PET/MR systemprovides simultaneous acquisition of high resolutionmetabolic and anatomic information from the two majorcomponents of each system (MR and PET). Additionalcomponents of the system include: a detachable patienttable and both the acquisition and processingworkstations with associated software.The SIGNA PET/MR includes a 3.0T superconductingmagnet, gradient coil and a transmit/receive whole bodyradiofrequency coil. The system includes patientadaptable RF shimming capabilities. The SIGNA PET
	detectors are integrated into the MR bore. This allows forsimultaneous, precisely aligned whole body MR and PETacquisitions. The PET subsystem supports Time of Flight(ToF) coincidence detection. The SIGNA PET/MRsoftware is used for patient management, datamanagement, scan control, image reconstruction andimage archival and evaluation. All images conform toDICOM imaging format requirements.
	The modifications to this system include the MotionFreeBrain software feature, which allows users the flexibility tocorrect patient head motion using the acquired PET datafrom the exam, without the need of external trackingdevices, additional MR data, or other motion tracking dataschemes.
Indications for Use:	The SIGNA PET/MR system combines magneticresonance diagnostic devices (MRDD) and PositronEmission Tomography (PET) scanners that provideregistration and fusion of high resolution physiologic andanatomic information, acquired simultaneously andisocentrically. The combined system maintainsindependent functionality of the MR and PET devices,allowing for single modality MR and / or PET imaging.
	These systems are intended to be utilized byappropriately trained health care professionals to aid inthe detection, localization, and diagnosis of diseases anddisorders. MR is intended to produce transverse, sagittal,coronal and oblique cross-sectional MR images,spectroscopic images and/or spectra, and displays theinternal structure and/or function of the human body.Other physical parameters derived from the imagesand/or spectra may also be produced. Depending on theregion of interest, approved contrast agents may be used,as described in their labeling. This system may also beused for imaging during interventional procedures whenperformed with MR compatible devices, such as MR safebiopsy needles.
	PET images and measures the distribution of PETradiopharmaceuticals in humans to aid the physician indetermining various metabolic (molecular) andphysiologic functions within the human body forevaluation of diseases and disorders such as, but notlimited to, cardiovascular disease, neurological disordersand cancer.
	The combined system utilizes the MR for radiation-freeattenuation correction maps for PET studies. The system
	provides inherent anatomical reference for the fused PETand MR images due to precisely aligned MR and PETimage coordinate systems.
Comparison ofTechnologicalCharacteristics:	The SIGNA PET/MR with the proposed software featureemploys the same fundamental technology as thepredicate device.
	The SIGNA PET/MR has been modified to include theMotionFree Brain feature. The user interface providesoperators of the system with an option for enabling thisfeature. MotionFree Brain derives head motioninformation from the PET data; there is no need forexternal tracking devices, additional MR data, oradditional PET data collection. The feature measuresand incorporates the rigid-body motion information intothe PET reconstruction, correcting the position of eachcoincidence event to account for patient head motion.
	These technological differences do not raise any differentquestions regarding safety and effectiveness. Bothdevices must allow for an effective method to setup anappropriate scan prescription. The performance datadescribed in this submission include results of both benchtesting and clinical testing that show the performance ofthe SIGNA PET/MR compared to the predicate device.
Summary of NonclinicalTesting:	The following quality assurance measures were appliedto the development of the device:• Risk Analysis• Requirements Reviews• Design Reviews• Verification (functional testing for subsystem andsystem integration)• Validation (simulated use testing)
	Non-clinical tests have been summarized in theverification and validation testing. The testing wascompleted with passing results per the pass/fail criteriadefined in the test cases. This supportssubstantial equivalence to its predicate because thesoftware feature was developed under quality assuranceDesign Controls. Performance testing on phantoms aspart of non-clinical testing demonstrated MotionFreeBrain achieved performance claims for Quantitation,Temporal Resolution, and Spatial Accuracy.

Summary of ClinicalTesting:	An external reader evaluation study was performed forMotionFree Brain. The retrospective blind study involvedboard-certified readers who were asked to evaluaterandomly labeled cases that were reconstructed with andwithout MotionFree Brain. Verification documents, validation documents, and testreports have been provided for more details. Testingdemonstrated that the device is as safe, as effective, andperforms as well as or better than the predicate device.No new questions of safety and effectiveness were raisedduring nonclinical testing.
	The readers were blinded to feature use (e.g. whetherfeature was enabled or disabled), report case history, aswell as to the assessments made by the other readers.The readers were asked to complete an assessment,including additional commentary, and report theirpreference on the pair of image series presented.
	Clinical testing confirms that MotionFree Brain can beused safely and effectively in a clinical setting.
Conclusion Drawn fromPerformance Testing:	The SIGNA PET/MR with the modified software featurehas the same intended use as the predicate. This 510(k)submission includes information on the technologicalcharacteristics of the proposed software feature, as wellas performance data demonstrating that the feature is assafe and effective as the predicate, and does not raisedifferent questions of safety and effectiveness.
	In conclusion, GE Healthcare considers the SIGNAPET/MR to be at least as safe and effective, and itsperformance is substantially equivalent to the predicatedevice.

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Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.